Table 16 Dissolution of the generic mesalazine enteric-coated formulation and reference drug determined by USP App3.
Medium | Time (h) | 21082305-2 (%) | 21091801-2 (%) | 20220927-1 (%) | L20084A (%) |
|---|---|---|---|---|---|
pH 1.2 | 2 | 0.1 | 0.1 | 0 | 0 |
pH 4.5 | 3 | 0.1 | 0.1 | 0 | 0 |
pH 5.5 | 4 | 0.1 | 0.1 | 0.3 | 0.1 |
pH 6.0 | 5 | 0.1 | 0.1 | 0.3 | 0.1 |
pH 6.8 (5 min) | 5.08 | 0.2 | 0.2 | 0.3 | 0.1 |
pH 6.8 (10 min) | 5.16 | 0.1 | 0.2 | 0.3 | 0.1 |
pH 6.8 (15 min) | 5.25 | 0.3 | 1.6 | 1 | 0.6 |
pH 6.8 (30 min) | 5.5 | 69 | 66 | 72 | 67.3 |
pH 6.8 (45 min) | 5.75 | 96.9 | 95.4 | 101.7 | 99.7 |
pH 6.8 (60 min) | 6 | 95.3 | 96.1 | 101.9 | 100.2 |
pH 6.8 (90 min) | 6.5 | 98.1 | 98.5 | 102.0 | 100.4 |
Similarity factor (f2) | 88 | 82 | 80 | --- | |
